Alzheimer's Association statement on a newly published study of Etanercept (Enbrel) for Alzheimer's

The Alzheimer’s Association welcomes new ideas for Alzheimer therapies, such as this. But we are concerned that, in their strong desire for more effective therapies, people with Alzheimer’s and their families may place undue value on this new finding based on the dramatic language used in its description and the apparent immediate effect. Special care needs to be taken when investigating and discussing drugs already on the market in order that they are not prescribed nor made available inappropriately based on preliminary findings and/or news media coverage.

This possible treatment strategy is very preliminary. This newly published study is a small one. In addition, one of the lead investigators has stock in the company that produces the drug and has a number of patent positions in the area. All of this strengthens the need for independent confirmation to establish this finding.

Before this drug can become an accepted therapy for Alzheimer’s disease, it would need to go through the FDA approval process, including randomized, blinded clinical trials. We need to see clinical studies in large, diverse populations. We need to see work in other laboratories by scientists without financial interest in the product. These things are only possible – for this and other potential therapies – if we have more resources available to the fight against Alzheimer’s.

In addition, this was not a registered, controlled clinical trial. Clinicians should not take this report as grounds for off-label use of Enbrel for Alzheimer's. The nature of the drug delivery technique used in this research (injection by needle into the back of the neck, followed by a brief period with the head lowered and feet elevated) is an unusual route for administering a drug intended for action on the brain. This unconventional route - designated by the authors as "perispinal" (meaning "near or around the spine") though never described in detail – makes Enbrel injection in this manner very unlikely to succeed in a chronic condition such as Alzheimer's, although this technique might form the basis for a "proof of concept" trial. Clinical trials of Enbrel delivered by this method should only be undertaken by investigators specially trained in safe administration of injection via this route (i.e., anesthesiologists or neurosurgeons).

The epidemic of Alzheimer's, and improving therapies and prevention

There is a growing epidemic of Alzheimer’s disease. Currently there are as many as 5 million people with Alzheimer’s disease. By 2050, experts predict that there may be as many as 16 million. By 2030, Medicare spending on those with Alzheimer’s alone may cost nearly $400 billion – roughly equivalent to today’s entire Medicare budget. Alzheimer’s could bankrupt the system and become the healthcare crisis of the 21st century.

That’s why we need better treatments and eventually prevention for Alzheimer’s. To do that, we need to follow through on established therapeutic targets and compounds, and also put more new treatment approaches into the pipeline. For example, a key principle of the Alzheimer’s Association’s grant funding is to give all good and viable ideas a chance – to fund the basic science that will uncover whether the idea is worth further investigation. If only we had more dollars with which to fund research projects. Donations can be made through our Web site – http://www.alz.org/.

The need for more resources in this fight is clear. The Alzheimer’s Association is confident that we will defeat Alzheimer’s disease. How fast we do it is directly related to the level of investment. In order to follow through on recent advances and get more new ideas into the pipeline, we need (1) more research dollars for Alzheimer’s disease, (2) more volunteers for clinical studies. Again, people can find out how to get involved at http://www.alz.org/.